Testing behavioral economics messages to increase non-responders' participation in organized colorectal cancer-screening programs: A randomized controlled trial.

This study aimed to evaluate the impact of behavioral economic-inspired messages on participation in colorectal cancer (CRC) screening programs. We conducted a randomized-controlled trial involving 11,505 non-responders to the CRC screening programs in Florence, Rome, and Turin in 2020. Participants aged 54-70 years were randomly assigned to four conditions. Individuals in the control conditions received a standard invitation letter while the three intervention groups included an additional paragraph featuring either i. normative feedback [F] message (giving feedback that invited subjects did not participate); ii. Minority norm [MN] message (only a minority did not participate); iii. F+ MN message (combining both messages). The primary outcome was the screening participation rate 90 days after the invitation was completed. A multivariate analysis was conducted adjusting for gender, age and birthplace. Overall, screening participation rates were 5.3% in the control condition, 7.0% in the F, 8.2% in the MN, and 7.4% in the F + MN arms (p = 0.002). Invited subjects in the MN arm were more likely to participate (adjusted Odds Ratio[aOR] = 1.38; 95% Confidence Interval [95%CI,1.13-1.68]), particularly those aged 54-59 years (aOR = 1.52; 95%CI:1.16-1.98), and 60-64 (aOR = 1.57; 95%CI:1.62-; 95%CI: 1.06-2.48). Additionally, individuals aged 60-64 invited in F and F + MN arms demonstrated a higher likelihood of participation (aOR for F arm = 1.60; 95%CI: 1.06-2.41; aOR for F + MN arm = 1.99; 95%CI: 1.35-2.92). The inclusion of MN and/or F messages in the invitation letter increased participation among previous non-responders <65 years. Behavioral economics is a promising area of interest for enhancing CRC screening participation. TRIAL REGISTRATION: ISRCTN registration number: ISRCTN11841256.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy, 2011-2012.

This annual survey, conducted by the Italian group for mammography screening (GISMa), collects individual data on diagnosis and treatment of about 50% of screen-detected, operated lesions in Italy. The 2011-2012 results show good overall quality and an improving trend over time. A number of critical issues have been identified, including waiting times (which have had a worsening trend over the years) and compliance with the recommendation of not performing frozen section examination on small lesions. Pre-operative diagnosis improved constantly over time, but there is still a large variation between Regions and programmes. For almost 90% of screen-detected invasive cancers a sentinel lymph node (SLN) biopsy was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN dissection for ductal carcinoma in situ, although apparently starting to decline, deserves further investigation. The detailed results have been distributed, among other ways by means of a web-based data-warehouse, to regional and local screening programmes, in order to allow multidisciplinary discussion and identification of the appropriate solutions to any issues documented by the data. The problem of waiting times should be assigned priority. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making monitoring effective in producing quality improvements with shorter waiting times.

[Audit system on quality of breast cancer diagnosis and treatment: results of quality indicators on screen-detected lesions in Italy, 2010]. / Il "progetto SQTM" sulla qualità di diagnosi e terapia entro i programmi di screening in Italia: risultati 2010.

This survey, conducted by the Italian breast screening network (GISMa), collects yearly individual data on diagnosis and treatment on about 50% of all screen-detected, operated lesions in Italy. The 2010 results show good overall quality and an improving trend over time. Critical issues were identified, including waiting times and compliance with the recommendations on not performing frozen section examination on small lesions. Preoperative diagnosis improved constantly over the years, but there is still a large variation between regions and programmes. For almost 90% of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN for ductal carcinoma in situ deserves further investigation. The detailed results have been distributed, also by means of a web data warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any issues documented by the data. It should be assigned priority to the problem of waiting times. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making monitoring effective in producing quality improvements with shorter waiting times.

Audit on quality of breast cancer diagnosis and treatment in Italy, 2008-2009.

This survey, conducted by the Italian breast screening network (GISMa), collects individual data yearly on about 50% of all screen-detected, operated lesions in Italy. The 2008-2009 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified, including waiting times and compliance with the recommendations on not performing frozen section examination on small lesions. Pre-operative diagnosis reached the acceptable target, but there is a large variation between regions and programmes. For almost 90% of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed, also by means of a web-based data warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any problem documented by the data. Specialist breast units with adequate case volume and enough resources would provide the best setting for making audits effective in producing quality improvements with shorter waiting times.

Risk of CIN2 in women with a pap test without endocervical cells vs. those with a negative pap test with endocervical cells: a cohort study with 4.5 years of follow-up.

OBJECTIVE: To measure the risk of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in the 4.5 years following a negative Pap smear with adequate endocervical cells (ECC) (+) or absent/scarce ECC (-). STUDY DESIGN: A prospective, nonconcurrent study of the archives of 11 Italian population-based screening programs was conducted. Only 25-50-year-old women with a first negative Pap test were included. RESULTS: Women were classified as ECC+ or ECC- and followed for 4.5 years. The endpoint was the occurrence of a CIN2+ histologic diagnosis. Eligible subjects with negative Pap tests ECC+ and ECC- numbered 469,694 and 20,596, respectively. At least 1 subsequent test was available during follow-up for 335,763 and 11,972 subjects, and 691 and 13 CIN2+ lesions were observed, respectively. The risk of CIN2+ was 2.06 and 1.09 per 1,000 women over 4.5 years, and age-adjusted relative risk associated with ECC--was 0.55 (95% CI 0.28-1.06). CONCLUSION: Women with a negative Pap ECC--have a lower risk of CIN2+ than women with a negative Pap ECC+ and should repeat screening with frequency (3-5 years in Europe), independent of age.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy, 2007.

This survey, conducted by the Italian Breast Screening Network (GISMa), collects individual data yearly on about 50% of all screen-detected, operated lesions in Italy. The 2007 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified concerning waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-rays. Preoperative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. For more than 80%of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed, also by means of a web data-warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any problem documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audits effective in producing quality improvements with a shorter waiting times.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy for 2006 and preliminary results for 2007.

Within this survey, conducted by the Italian Breast Screening Network (Gruppo Italiano per lo Screening Mammografico, GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2006, results showed overall good diagnosis and treatment quality and an improving trend over time. Critical issues were identified in waiting times, compliance with recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN in ductal carcinoma in situ deserves further investigation. The detailed results have been distributed to regional and local screening programmes, also by means of an online database, in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audit effective in producing quality improvement with a shortening of waiting times.

Can colorectal cancer mass-screening organization be evidence-based? Lessons from failures: the experimental and pilot phases of the Lazio program.

BACKGROUND: Screening programmes should be organized to translate theoretical efficacy into effectiveness. An evidence-based organizational model of colorectal cancer screening (CRCS) should assure feasibility and high compliance. METHODS: A multidisciplinary Working Group (WG), reviewed literature and guidelines to define evidence-based recommendations. The WG identified the need for further local studies: physicians' CRCS attitudes, the effect of test type and provider on compliance, and individual reasons for non-compliance. A survey of digestive endoscopy services was conducted. A feasibility study on a target population of 300.000 has begun. RESULTS: Based on the results of population trials and on literature review the screening strategy adopted was Faecal Occult Blood Test (FOBT) every two years for 50-74 year olds and, for positives, colonoscopy. The immunochemical test was chosen because it has 20% higher compliance than the Guaiac. GPs were chosen as the preferred provider also for higher compliance. Since we observed that distance is the major determinant of non-compliance, we choose GPs because they are the closest providers, both geographically and emotionally, to the public. The feasibility study showed several barriers: GP participation was low, there were administrative problems to involve GPs; opportunistic testing by the GPs; difficulties in access to Gastroenterology centres; difficulties in gathering colonoscopy results; little time given to screening activity by the gastroenterology centre. CONCLUSION: The feasibility study highlighted several limits of the model. Most of the barriers that emerged were consequences of organisational choices not supported by evidence. The principal limit was a lack of accountability by the participating centres.

Efficacy of disease management profiles. The mammographic screening program of Lazio.

BACKGROUND: Screening programs are considered disease management profiles. The aim of the present study was to evaluate the efficacy of screening programs compared to regularly offered health care services, using early outcomes and process indicators. METHOD: In the study period (1/7/99-30/6/01), six breast cancer screening programs were active in 12 health districts in the Lazio region of Italy. Screening histories of all the incident cases of women surgically treated for a breast neoplasm were reconstructed (not contacted, contacted, non-participants, participants). The subpopulations were then compared for the appropriateness of treatments received. RESULTS: We identified 3251 women who were treated for malignant neoplasms of the breast and 1562 treated for benign neoplasms. The incidence of malignant neoplasms was higher in the women contacted for screening (incidence rate ratio, 1.45; 95% CI, 1.32-1.60), and the incidence of treatment for non-malignancies was similar in the two populations (incidence rate ratio, 1.00: 95% CI, 0.86-1.16). The percentage of surgery for non-malignancies detected by screening was 16.7%, whereas among the cases diagnosed outside a screening program it was 33.8%. Of malignancies detected outside of screening, 16.6% had a surgical treatment that was too invasive, among the screen-detected malignancies the percentage fell to 11% (prevalence rate ratio, 0.66; 95% CI, 0.48-0.91). Women contacted for screening showed a higher incidence of localized and in situ tumors, whereas the incidence of non-localized and metastatic tumors was basically the same in the two groups. CONCLUSIONS: The first round of screening programs led to more surgical interventions, a similar incidence of mastectomy and of interventions for benign neoplasm, but a lower incidence of unnecessary treatment.

Audit system on quality of breast cancer diagnosis and treatment (QT): results of quality indicators on screen-detected lesions in Italy in 2005 and preliminary results for 2006.

Within this survey, conducted by the Italian Group of Mammography Screening (GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2005, results showed overall good diagnosis and treatment quality, and an improving trend over time. Critical issues were identified in waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis has reached the acceptable target, but room for improvement still exists. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed to local and regional screening programmes in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume would provide the best setting for making audit effective in producing quality improvement.

Dying of cancer in Italy: impact on family and caregiver. The Italian Survey of Dying of Cancer.

OBJECTIVE: To describe the effect of terminal cancer on the patient's family, finances and daily life. METHODS: A cluster sample of 2000 adults (> or = 18 years old) who had died from cancer, and who were representative of Italy, was studied. 1900 caregivers were identified and 68% responded to a post-bereavement survey. Caregivers included the patient's child (46%), his/her spouse (31%), other relatives or friends (20%) or a health professional (3%). The median age of a caregiver was 54 years and 69% were females. During the last 3 months of the patient's life, 44% of caregivers reported difficulties in their regular employment. RESULTS: Of the 68% of families who had to pay for some of the care, 37% had to pay for drugs, 36% for nursing and assistance and 22% for physicians. Paying for care was more frequent in the south of Italy (OR 2.5; 95% CI 1.0 to 6.3) and when the patient was a housewife (OR for unit increase 2.7; 95% CI 1.6 to 6.1). To cover the costs of patient care, 26% of families used all or most of their savings. Economic difficulties were greater in the south of Italy (OR 3; 95% CI 1.8 to 5.1), for female caregivers (OR 1.4; 95% CI 1.0 to 1.9) and for disadvantaged patients. The duration of time the patient was completely dependent strongly determined the effect caregiving had on their regular employment and on the family's financial situation. CONCLUSIONS: Although in Italy families are responsible for a small percentage of the overall costs of patient care, the effect of cancer on savings and daily life can be substantial. Strong geographical and gender differences emerged from this study.

[Socio-economic status and family profile indicators: methodological issues in studying the burden of caregiving for terminally ill cancer patients]. / Indicatori di stato socio-economico e profili familiari: problemi metodologici nello studio dell'impatto sulle famiglie della fase terminale della malattia oncologica.

INTRODUCTION: The quality of care received by terminally ill cancer patients depends heavily on socio-economic conditions and family resources, especially because of the current increase in home care assistance. OBJECTIVE: To validate the demographic information on educational level which is recorded in the registries of residents in Italian towns; to compare simple indicators of socio-economic status and family profiles with composite indicators in their ability to predict the economic and social impact of the disease. DESIGN: A two-level probabilistic sample of cancer deaths from the Italian Survey on Dying Of Cancer. PARTICIPANTS: 2000 deaths were sampled; caregivers were identified and interviewed between 4 and 12 months after the patient's death. METHODS: We calculated Cohens kappa for educational level as reported in the registry, and in the questionnaire. We constructed a composite indicator of socio-economic status and family profile using a cluster analysis; its association with the impact on finances and quality of daily life was compared with that from the educational level reported in the questionnaire and with a previously derived indicator of family profile. RESULTS: The weighted kappa of the two sources used for educational level was 0.60 (CI 95% 0.55-0.64). Of the two indicators, educational level and socio-economic status (6 groups), only the later showed a significant association with the outcomes "difficulties" in sustaining the costs of treatment" and "use of entire savings for the illness". The composite indicator of family profile (7 groups) was significantly associated with all outcomes considered. Log-likelihood was significantly better with model using the composite and the prior indicators of family profile than in models without them. Models that included educational level and prior indicator of family profile (7 groups) were more adaptable than models with the composite indicators. CONCLUSIONS: The good level of agreement between the two sources regarding educational level suggests that the registry is an adequate data source, when other information is lacking. Our study did not reveal which of the indicators we used is the best, at least with regard to the outcomes we considered.

Audit system on quality of breast cancer diagnosis and treatment (QT): results from the survey on screen-detected lesions in Italy, 2004.

Within this survey, conducted by the Italian Group for Mammography Screening (GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2004, overall results show a good diagnosis and treatment quality and an improving trend over time. Critical issues have been identified in waiting times, compliance to the recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis has reached an acceptable level, but room for improvement still exists. The sentinel lymph node technique (SLN) was performed on the axilla in almost 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed to local and regional screening programmes in order to enable multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volumes would provide the best setting for effective audits leading to quality improvement.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results from the survey on screen-detected lesions in Italy, 2003-2004.

Within the Italian Breast Screening Network, individual data are collected yearly on about 50% of all screen-detected operated lesions. In 2003 results showed a good overall quality of diagnosis and treatment, and an improving trend over time. Critical issues were identified in the number of cancers diagnosed pre-operatively, which is still below standards, and in the waiting times for surgery. Compliance with recommendations as to not performing frozen section on small lesions and unnecessary axillary dissection for ductal carcinoma in situ still have not reached the target. The sentinel lymph node technique was performed on the axilla in more than 60% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. Preliminary data for 2004 show further progress towards better quality, particularly in pre-operative diagnosis and in the avoidance of frozen section. The detailed results of this survey have been distributed to local and regional screening programmes in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume would provide the best setting for making audit effective in producing quality improvement.

Direct mailing of faecal occult blood tests for colorectal cancer screening: a randomized population study from Central Italy.

BACKGROUND: Sending faecal occult blood tests (FOBT) by mail has been proposed both as a method to increase participation and a way to reduce staff costs in colorectal cancer screening. METHODS: Two multicentre randomized controlled trials (ISRCTN10351276) were performed: one randomly assigned 3196 individuals who had previously participated in colorectal screening to receive a FOBT kit at home or a standard invitation; in the second, 4219 people aged 50-69 years who did not respond to a screening invitation were either sent a FOBT or a standard recall letter. The cost per returned kit was calculated in each arm. RESULTS: Participation was higher with direct FOBT mailing in both trials: relative risk 1.11 (95% CI 1.06-1.17) and 1.36 (95% CI 1.16-1.60) for previous responders and non-responders, respectively. The cost per returned kit for previous responders ranged from 4.24€ to 16.10€, and from 3.29€ to 7.36€ with FOBT mailing and standard invitation, respectively, not including staff costs; for non-responders it ranged from 17.13€ to 46.80€, and from 7.36€ to 18.30€ with FOBT mailing and standard recall, respectively. CONCLUSIONS: The FOBT mailing strategy modestly increased participation. This method can be used on a population of previous responders to reduce personnel costs and workload. When used as a reminder to non-responders, this method increases costs.

Validating regional Hospital Information System data through comparison with a local cancer register to identify interval cancers of a breast screening program.

The objective of this study was to evaluate the accuracy of the Hospital Information System (HIS) in monitoring the breast cancer incidence and interval cancers compared with the cancer registry (CR). The HIS data linked with CR and Mammographic Screening Information System data for breast cancer cases diagnosed in the period 1999-2003. The sensitivity and positive predictive value of the HIS data were calculated using the CR as a gold standard. One thousand two hundred and thirty-six breast cancers were registered by the CR and 1028 were reported in the HIS. The sensitivity rate was 83.2% and the positive predictive value was 83.0%; similar results were obtained in the screening target population (50-69 years old). Fifteen invasive breast cancers occurred among screened women identified by HIS (four interval cancers and 11 screen-detected), two were registered as in situ in the CR. The HIS seems to have the potential to identify interval breast cancers, but the low accuracy of information does not permit an exact measure of the incidence.